To investigate whether IC administration of abciximab during primary PCI is superior to IV administration in improving myocardial perfusion in patients with STEMI.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point is >70% ST-segment elevation resolution, a marker of
myocardial perfusion.
Secondary outcome
Secondary end points are electrocardiographic and angiographic measures of
myocardial reperfusion, infarct size, and clinical outcome at 30 days and 1
year.
Background summary
Intravenous (IV) administration of abciximab during primary percutaneous
coronary intervention (PCI) plays an important role in the treatment of
patients with ST-segment elevation myocardial infarction (STEMI). There is,
however, still a high incidence of diminished post-procedural myocardial
perfusion, which is associated with poorer clinical outcomes. Recent
small-scale studies have indicated that intracoronary (IC) administration of
abciximab instead of the (IV) route is associated with improved post-procedural
myocardial perfusion.
Study objective
To investigate whether IC administration of abciximab during primary PCI is
superior to IV administration in improving myocardial perfusion in patients
with STEMI.
Study design
The study is a single-center, prospective, randomized trial with blinded
evaluation of endpoints.
Intervention
During the PCI procedure patients are randomised to receive weight-adjusted
abciximab either through the IC or IV route.
Study burden and risks
Currently available clinical evidence documents a risk profile of IC
administration of abciximab comparable to IV administration. IC administration
of abciximab is not associated with any treatment delay or additional exposure
to radiation during PCI. No additional visits or tests are needed except for a
questionnaire and/or contact through telephone to assess clinical outcomes. If
IC administration of abciximab is superior to IV administration, this finding
will give support to incorporating IC use of abciximab into the standard
treatment regimen during primary PCI.
Hanzeplein 1
9700 RB Groningen, Postbus 30.001
NL
Hanzeplein 1
9700 RB Groningen, Postbus 30.001
NL
Listed location countries
Age
Inclusion criteria
- a diagnosis of STEMI defined by
a. chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
b. time from onset of symptoms of less than 12 hours
c. ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads
- primary PCI performed
- verbal followed by written informed consent
Exclusion criteria
-rescue PCI after thrombolytic therapy
-need for emergency coronary artery bypass grafting
-presence of cardiogenic shock
-known existence of a life-threatening disease with a life expectancy of less than 6 months
-inability to provide informed consent
-age below 18 years
-Contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensie or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004485-12-NL |
| CCMO | NL24305.042.08 |